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U.S. Department of Health and Human Services

Class 2 Device Recall Kerlix Gauze Roll

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  Class 2 Device Recall Kerlix Gauze Roll see related information
Date Initiated by Firm August 01, 2018
Create Date October 03, 2018
Recall Status1 Terminated 3 on June 03, 2020
Recall Number Z-0015-2019
Recall Event ID 80924
510(K)Number K990530  
Product Classification Dressing, wound, occlusive - Product Code NAD
Product Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880

Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Code Information Lot Numbers: 18E030462,18E223262,18F122962
Recalling Firm/
Manufacturer		 COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact
508-261-8000
Manufacturer Reason
for Recall		 Potential for product sterility breach due to a compromised or pinched seal defect
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On August 1, 2018 Cardinal Health issued Urgent Medical Device Recall notices to U.S. customers via Fed Ex and OUS customers were directly contacted by Quality & Regulatory Affair representatives supporting that country. Customers were advised to take the following actions: 1. Inspect stock and quarantine affected product. 2. Immediately stop using affected product. 3. Return the completed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from customers, and to prevent further notices. 4. Notify any customers to whom you may have distributed product affected by this recall. 5. Contact the appropriate Customer Service group to arrange for credit and return of any affected product you may have: ¿ Hospital 800-964-5227 ¿ Federal Government 800-444-1166 ¿ Distributors800-635-6021 ¿ All other customers 888-444-5440 Customers with any questions regarding this letter may call (800) 292-9332.
Quantity in Commerce 2,730,821 units in total
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAD and Original Applicant = THE KENDALL COMPANY, L.P.
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